Clinical Research Associate - Germany (Remote, 0.8-1.0 FTE)

About Us

P95 and Julius Clinical have recently merged to create a combined global entity dedicated to advancing health worldwide through high-quality epidemiological studies and clinical trials. P95, established in 2011 and based in Belgium, is a prominent leader in epidemiology, vaccines, and infectious disease research, serving public health agencies, pharmaceutical companies, academic institutions, and international organizations. Julius Clinical, founded in 2008 in The Netherlands, is a highly regarded clinical contract research organization specializing in central nervous system, cardio-metabolic, renal, and rare diseases, with a strong record of over 400 trials and 300,000 participants enrolled globally. Together, they form a science-driven global research organization delivering integrated epidemiological and clinical research services with operational excellence and scientific leadership. Both are part of Ampersand Capital Partners' healthcare investment portfolio.

Role Overview and Responsibilities

The Clinical Research Associate (CRA) will take on responsibilities that include but are not limited to:

• Conducting visits such as Site Selection, Site Initiation, Monitoring, and Close-Out to clinical trial sites.
• Overseeing trial sites to ensure compliance with study protocols, sponsor guidelines, and regulatory requirements.
• Performing Source Data Verification and Review to confirm data validity.
• Assessing informed consent processes to guarantee patient safety and regulatory adherence.
• Detecting and tracking protocol deviations and other study-related issues.
• Providing ongoing support to clinical sites by addressing protocol questions and study concerns.
• Maintaining clear and effective communication channels between investigators, site staff, sponsors, and internal teams.
• Creating detailed monitoring reports within specified timeframes.
• Ensuring all essential trial documentation is complete and ready for potential inspections.
• Participating in risk-based monitoring and quality oversight activities to uphold study standards.
• Supporting all trial phases including start-up, recruitment, ongoing management, and close-out procedures.
• Attending investigator and team meetings along with training sessions as necessary.

Candidate Profile and Requirements

• Possess a Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Sciences, or related disciplines.
• Have at least two years of practical experience as a CRA with exposure to investigational products (IP) preferred.
• Demonstrate comprehensive knowledge of ICH-GCP guidelines, clinical trial regulations, and monitoring methodologies.
• Experience independently conducting monitoring visits across several sites.
• Exhibit resilience under pressure and the ability to manage multiple priorities efficiently.
• Strong problem-solving aptitude with a proactive stance toward challenges.
• Well-developed planning and organizational capabilities for managing complex tasks.
• Effective collaboration skills and a constructive approach to resolving team and client issues.
• Commitment to accuracy, quality, and high standards in deliverables.
• Adaptability and flexibility in fast-changing environments.
• Fluency in both written and spoken German and English languages.
• Residency within Germany and willingness to undertake frequent domestic travel alongside occasional international travel.
• Excellent communication and interpersonal abilities.
• Ability to work independently while also thriving in a team setting.
• Detail-oriented with a strong drive to complete work efficiently.
• Microsoft Office proficiency and openness to learning new software tools.
• Cultural awareness and aptitude for working collaboratively in international teams.